MAUDE Adverse Event Report: PRINGY JUVEDERM VOLUX XC 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	20073770
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a patient in the chin, marionette lines, prejowl, and jawline with 1 syringe of juvéderm® volux¿ xc.The patient was concomitantly injected with 2 syringes of revanesse® versa¿+.Five months later, the patient developed a ¿persistent pea-sized nodule¿ on the mid-jawline on the left side.The nodule was dissolved with 210 u of hyaluronidase.Two months later, the patient returned with a ¿smaller than pea-size nodule¿ mid-to-medial jawline on the right side.The patient was treated with 190 u of hyaluronidase, and a needle was used to break it up more.The patient reported being ¿unable to stop touching it or playing with it.¿ this led to feeling it ¿break up and them come back together.¿ the patient felt ¿irritation from excessively touching it.¿ two weeks later, the patient was treated with another 100 u of hyaluronidase (50 u diluted 1:1 with bacteriostatic saline).The was more ¿significant swelling¿ after the latest round.Two days later, at the patient¿s insurance, another 150 u of hyaluronidase was given.The nodule remained ¿the size of a grain of rice.¿ event is ongoing.
Additional Manufacturer Narrative
Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.

• Brand Name: JUVEDERM VOLUX XC 2 X 1ML
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23650228
• Report Number: 3005113652-2025-01076
• Device Sequence Number: 11954478
• Product Code: LMH
• UDI-Device Identifier: 10840228300073
• UDI-Public: (01)10840228300073(10)1000575279(11)230202(17)250102
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2025
• Device Catalogue Number: 20073770
• Device Lot Number: 1000575279
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female